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GSK presents IIIb MUSCA study analysis in DC

22 May 2017 14:28

GlaxoSmithKline has presented data from a post-hoc analysis of the phase IIIb MUSCA study in which first-in-class biologic Nucala (mepolizumab) consistently improved health-related quality of life and lung function in patients with severe asthma across blood eosinophil levels of 150 cells/µL and above.

The data also showed an association between increasing lung function improvement and increasing eosinophil levels.

The analysis presented at the American Thoracic Society (ATS) conference, Washington DC, US, looked at treatment response at week 24 in patients treated with mepolizumab compared to placebo, both added to standard of care (high dose inhaled corticosteroids plus at least one additional controller). The data showed that for patients in the mepolizumab arm:

- Quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ) score, improved by 7.8 units (95% CI: -11.0, -4.7), 8.2 units (95% CI: -12.2, -4.2) and 7.7 units (95% CI: -13.3, -2.1) versus placebo in patients with blood eosinophils of ?150, ?300 and ?500 cells/mL respectively - improvements were approximately double the defined clinically meaningful difference of 4.0 units at each of the three blood eosinophil thresholds.

- Lung function, as measured by pre-bronchodilator FEV1, increased by 137mL (95% CI: 56, 218), 165mL (95% CI: 64, 265) and 206mL (95% CI: 77, 335) versus placebo in patients with blood eosinophils of ?150, ?300 and ?500 cells/mL respectively - all improvements were clinically relevant.

The MUSCA study is the first study designed to primarily assess the effect of mepolizumab on disease-specific health-related quality of life. Lung function was the first secondary endpoint. The post-hoc analysis also examined exacerbation rate and asthma control by eosinophil threshold, both of which improved in mepolizumab-treated patients in line with findings from previous studies. In addition to providing further data on these endpoints, the findings of the post-hoc analysis reinforce prior studies demonstrating the utility of a blood eosinophil threshold of ?150 cells/µL for the identification of patients with severe asthma and frequent exacerbations, despite high-dose ICS plus other controller(s), likely to benefit from treatment with mepolizumab.

Dr Frank Albers, Global Medical Affairs Lead for Nucala, GSK said: "Eosinophil levels in the blood are used to help identify severe asthma patients who may be appropriate for treatment with Nucala. This post-hoc analysis of the MUSCA study shows that Nucala has the potential to offer meaningful improvements in important clinical endpoints, as well as patient-reported outcomes, in severe asthma patients with blood eosinophil levels of 150 cells/mL and above. It provides additional useful information for clinicians as they make important treatment choices for their severe asthma patients with an eosinophilic phenotype."

At 2:28pm: (LON:GSK) GlaxoSmithKline PLC share price was +1p at 1648.5p

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